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Rekambys is a brand name for Rilpivirine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: REKAMBYS is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen…
Verbatim from this product's EMA label. Tap a section to expand.
Therapy should be prescribed by a physician experienced in the management of HIV infection. Each injection should be administered by a healthcare professional. Prior to starting REKAMBYS, the healthcare professional should carefully select patients who agree to the required injection schedule and counsel patients about the importance of adherence to scheduled dosing visits to help maintain viral suppression and reduce the risk of viral rebound and potential development of resistance associated with missed doses.
4). The prescribing information for cabotegravir injection should be consulted for recommended dosing. 3 Posology REKAMBYS (rilpivirine injection) may be initiated with oral lead-in or without (direct to injection). The healthcare professional and patient may decide to use rilpivirine tablets as an oral lead-in prior to the initiation of rilpivirine injections to assess tolerability (see Table 1), or proceed directly to rilpivirine injections (see Tables 2 and 3, for monthly and every 2 months dosing recommendations, respectively).
Adults and adolescents (at least 12 years of age and weighing at least 35 kg) Oral lead-in When used for oral lead-in prior to the initiation of REKAMBYS, rilpivirine oral tablets, together with cabotegravir oral tablets, should be taken for approximately 1 month (at least 28 days) to assess tolerability to rilpivirine and cabotegravir.
One rilpivirine 25-mg tablet should be taken with a meal with one cabotegravir 30-mg tablet once daily (see Table 1). Table 1 Oral Lead-in Dosing Schedule Oral Lead-In Drug For one month (at least 28 days), followed by the Initiation Injectiona Rilpivirine 25 mg once daily with a meal Cabotegravir 30 mg once daily a see Table 2 for monthly injection dosing schedule and Table 3 for every 2 months injection dosing schedule.
Every 1 month dosing Initiation injection (900 mg corresponding to 3 mL) On the final day of current antiretroviral therapy or oral lead-in, the recommended initiation injection dose of rilpivirine is a single 900 mg intramuscular injection.
Continuation injection (600 mg corresponding to 2 mL) After the initiation injection, the recommended continuation injection dose of rilpivirine is a single 600 mg monthly intramuscular injection. Patients may be given injections up to 7 days before or after the date of the monthly injection schedule.
Summary of the safety profile The most frequently reported ARs were injection site reactions, headache, and pyrexia. Tabulated summary of adverse reactions The ARs identified for rilpivirine and/or cabotegravir are listed by system organ class (SOC) and frequency (see Table 7).
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100). Table 7 Tabulated summary of adverse reactions1 MedDRA System Organ Class (SOC) Frequency Category ARs for rilpivirine + cabotegravir regimen Blood and lymphatic system disorders Common decreased white blood cell count2, decreased haemoglobin2, decreased platelet count2 Immune System Disorders Uncommon immune reactivation syndrome2 Metabolism and nutrition disorders Very common increased total cholesterol (fasted)2, increased LDL cholesterol (fasted)2 Common decreased appetite2, increased triglycerides (fasted)2 Psychiatric disorders Common depression, anxiety, abnormal dreams, insomnia, sleep disorder2, depressed mood2 Nervous system disorders Very common headache 13 Common dizziness Uncommon somnolence, vasovagal reactions (in response to injections) Gastrointestinal disorders Very common increased pancreatic amylase2 Common nausea, vomiting, abdominal pain3, flatulence, diarrhoea, abdominal discomfort2, dry mouth2, increased lipase2 Hepatobiliary disorders Uncommon hepatotoxicity Skin and subcutaneous tissue disorders Common rash4 Musculoskeletal and connective tissue disorders Common myalgia General disorders and administrative site conditions Very common injection site reactions (pain and discomfort, nodule, induration), pyrexia5 Common injection site reactions (swelling, erythema, pruritus, bruising, warmth, haematoma), fatigue, asthenia, malaise Uncommon injection site reactions (cellulitis, abscess, anaesthesia, haemorrhage, discolouration) Investigations Common weight increased Uncommon transaminase increased, blood bilirubin increased 1 The frequency of the identified ARs are based on all reported occurrences of the events and are not limited to those considered at least possibly related by the investigator.
Risk of resistance following treatment discontinuation To minimise the risk of developing viral resistance it is essential to adopt an alternative, fully suppressive antiretroviral regimen no later than one month after the last every 1 month injection of rilpivirine or two months after the last every 2 months injection of rilpivirine.
If virologic failure is suspected, an alternative regimen should be adopted as soon as possible. 9). Baseline factors associated with virological failure Before starting the regimen, it should be taken into account that multivariable analyses indicate that a combination of at least 2 of the following baseline factors may be associated with an increased risk of virological failure: archived rilpivirine resistance mutations, HIV-1 subtype A6/A1, or BMI ≥ 30 kg/m2.
Available data suggest that virologic failure occurs more often when these patients are treated according to the every 2 months dosing schedule as compared to the monthly dosing regimen. 1). 7 Post-injection reactions Accidental intravenous administration may result in Adverse Reactions due to temporarily high plasma concentrations.
In clinical studies, serious post-injection reactions were reported within minutes after the injection of rilpivirine. , back and chest). These events were very rare and began to resolve within minutes after the injection. Some of the patients received symptomatic treatment, at the discretion of the treating physician.
2). Patients should be briefly observed (approximately 10 minutes) after the injection. If a patient experiences a post-injection reaction, monitoring and treatment should be provided as clinically indicated. Cardiovascular Rilpivirine should be used with caution when co-administered with a medicinal product with a known risk of Torsade de Pointes.
2). Oral rilpivirine at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc. Plasma rilpivirine concentrations after rilpivirine injections are comparable to those during such oral rilpivirine therapy.
1. 5): - the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin - the antimycobacterials rifabutin, rifampicin, rifapentine - the systemic glucocorticoid dexamethasone, except as a single dose treatment - St John’s wort (Hypericum perforatum).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Table 2 Recommended monthly intramuscular injection dosing schedule Medicinal Product Initiation injection Continuation injections Initiate injection on the last day of either current ART therapy or oral lead-in (if used) One month after initiation injection and monthly onwards Rilpivirine 900 mg 600 mg Cabotegravir 600 mg 400 mg Every 2 months dosing Initiation Injections –1 month apart (900 mg corresponding to 3 mL) On the final day of current antiretroviral therapy or oral lead-in, the recommended initial rilpivirine injection dose is a single 900 mg intramuscular injection.
One month later, a second 900 mg intramuscular injection should be administered. Patients may be given the second 900 mg injection up to 7 days before or after the scheduled dosing date. Continuation Injections – 2 months apart (900 mg corresponding to 3 mL) After the initiation injections, the recommended rilpivirine continuation injection dose is a single 900 mg intramuscular injection administered every 2 months.
Patients may be given injections up to 7 days before or after the date of the every 2 months injection schedule. 4 Table 3 Recommended every 2 months intramuscular injection dosing schedule Initiation injections Continuation injections Medicinal Product Initiate injection on the last day of either current ART therapy or oral lead-in (if used).
One month later, a second initiation injection should be administered. Two months after last initiation injection and every 2 months onwards Rilpivirine 900 mg 900 mg Cabotegravir 600 mg 600 mg Dosing recommendations when switching from monthly to every 2 months injections Patients switching from a monthly continuation injection schedule to an every 2 months continuation injection schedule should receive a single 900 mg intramuscular injection of REKAMBYS one month after the last 600 mg REKAMBYS continuation injection dose and then 900 mg every 2 months thereafter.
Dosing recommendations when switching from every 2 months to monthly injections Patients switching from an every 2 months continuation injection schedule to a monthly continuation injection schedule should receive a single 600 mg intramuscular injection of REKAMBYS two months after the last 900 mg REKAMBYS continuation injection dose and then 600 mg monthly thereafter.
Missed doses Patients who miss an injection visit should be clinically reassessed to ensure resumption of therapy is appropriate. See Table 4 and 5 for dosing recommendations after a missed injection. Missed every 1 month injection (Oral Dosing to Replace Up to 2 Consecutive Monthly Injections) If a patient plans to miss a scheduled injection by more than 7 days, daily oral therapy (one rilpivirine tablet [25 mg] and one cabotegravir tablet [30 mg]) may be used to replace up to 2 consecutive monthly injection visits.
1. The first dose of oral therapy should be taken 1 month (± 7 days) after the last injection doses of REKAMBYS and cabotegravir. Injection dosing should be resumed on the day oral dosing completes, as recommended in Table 4. , missing more than two monthly injections, an alternative oral regimen should be initiated one […]
2 Additional adverse reactions seen with oral rilpivirine in other studies. 3 Abdominal pain includes the following grouped MedDRA preferred term: abdominal pain, upper abdominal pain. 4 Rash includes the following grouped MedDRA preferred terms: rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash morbilliform, rash papular, rash pruritic.
5 Pyrexia includes the following grouped MedDRA preferred terms: pyrexia, feeling hot, body temperature increased. The majority of pyrexia events were reported within one week of injections. The overall safety profile at week 96 and week 124 in the FLAIR study was consistent with that observed at week 48, with no new safety findings identified.
In the extension phase of the FLAIR study, initiating the rilpivirine plus cabotegravir injection regimen without oral lead-in (direct to injection) was not associated with any new safety concerns related to omitting the oral lead-in phase.
Description of selected adverse reactions Local Injection Site Reactions (ISRs) Up to 1% of subjects discontinued treatment with rilpivirine and cabotegravir injections because of ISRs. Injection site reactions were generally mild (Grade 1, 70%-75% of subjects) or moderate (Grade 2, 27%-36% of subjects).
3-4% of subjects experienced severe (Grade 3) ISRs. The median duration of ISR events was 3 days. The percentage of subjects reporting ISRs decreased over time. 0 kg (pooled analysis). 3 kg in the CAR arms. 0 kg. 14 Changes in laboratory chemistry Elevated transaminases (ALT/AST) were observed in subjects receiving rilpivirine plus cabotegravir during the clinical studies.
These elevations were primarily attributed to acute viral hepatitis. A few subjects on oral rilpivirine plus oral cabotegravir treatment had transaminase elevations attributed to suspected drug-related hepatotoxicity; these changes were reversible upon discontinuation of treatment.
Small, non-progressive increases in total bilirubin (without clinical jaundice) were observed with treatment with rilpivirine plus cabotegravir. These changes are not considered clinically relevant as they likely reflect competition between cabotegravir and unconjugated bilirubin for a common clearance pathway (UGT1A1).
Elevated lipases were observed during clinical trials with rilpivirine plus cabotegravir. Grade 3 and 4 lipase increases occurred at a higher incidence with rilpivirine plus cabotegravir compared with CAR. These elevations were generally asymptomatic and did not lead to rilpivirine plus cabotegravir discontinuation.
One case of fatal pancreatitis with Grade 4 lipase and confounding factors (including history of pancreatitis) has been reported in study ATLAS-2M for which the causality to the injection regimen could not be ruled out. Paediatric population Based on data from the week 16 (Cohort 1; n=25) and week 24 (Cohort 2; n=144) analyses of the MOCHA study (IMPAACT 2017), no new safety concerns were identified in adolescents (aged at least 12 years and weighing 35 kg or more) when compared with the safety profile established in adults.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the […]
HBV/HCV co-infection Patients with hepatitis B co-infection were excluded from studies with rilpivirine. It is not recommended to initiate rilpivirine in patients with hepatitis B co-infection. In patients co-infected with hepatitis B receiving oral rilpivirine, the incidence of hepatic enzyme elevation was higher than in patients receiving oral rilpivirine who were not hepatitis B co-infected.
Physicians should refer to current treatment guidelines for the management of HIV infection in patients co-infected with hepatitis B virus. Limited data is available in patients with hepatitis C co-infection. In patients co-infected with hepatitis C receiving oral rilpivirine, the incidence of hepatic enzyme elevation was higher than in patients receiving oral rilpivirine who were not hepatitis C co-infected.
The pharmacokinetic exposure of oral and injectable rilpivirine in co-infected patients was comparable to that in patients without hepatitis C co-infection. Monitoring of liver function is recommended in patients with hepatitis C co-infection.
5). Pregnancy There are limited data of rilpivirine in pregnant women. Rilpivirine is not recommended during pregnancy unless the expected benefit justifies the potential risk. Lower exposures of oral rilpivirine were observed when rilpivirine 25 mg once daily was taken during pregnancy.
In the Phase 3 studies with oral rilpivirine, lower rilpivirine exposure, similar to that seen during pregnancy, has been associated with an increased risk of virological failure, therefore viral load should be monitored closely. 2).
8 Immune reactivation syndrome In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART. Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary. Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reconstitution, however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Opportunistic infections Patients should be advised that rilpivirine or any other antiretroviral therapy does not cure HIV infection and that they may still […]